Motiva Flora Tissue Expander PMCF

Inclusion Criteria

• The participant gives written informed consent.

• The participant is genetically female, aged 18 years or older.

• The participant needs tissue expansion as part of breast reconstruction treatmentfollowing mastectomy, which may include immediate reconstruction.

• The participant is in a suitable clinical condition to allow breast implantplacement after tissue expander placement, at the discretion of the investigator.

• The participant has the physical and cognitive capacity to understand and follow thesurgeon's recommendations.

• Complete radiotherapy at least 1 year before surgery.

• Partial or total decrease in tumour volume after radiotherapy.

• The participant is able and willing to comply with all study requirements includingattending follow-up appointments.

• Participant with reasonable surgical risk.

• Participant with a history of non-metastatic breast cancer.

• Participant willing to undergo an MRI, CT scan and any other studies if required atsurgeon discretion.

For substudy - MRI / CT - the following additional criteria apply:

• Patient is willing to undergo one MRI and one CT anytime during the follow up

Exclusion Criteria:

• The participant is pregnant or planning a pregnancy during the first year aftersurgery or is currently breastfeeding.

• Participants with implanted devices that may be affected by magnetic fields (pacemakers, drug infusion devices).

• Participants with abnormal haematological and biochemical values after chemotherapy.

• Participants with tumour residues in or near the area where tissue expansion is tobe performed.

• Participants who do not have adequate tissue at the intended site for expansion, atthe surgeon's discretion, due to previous radiotherapy, ulceration, vascularinvolvement, history of impaired wound healing or scar deformity.

• Participants with current or previous infection in the area where the expansion willtake place.

• Presence of autoimmune diseases such as lupus or scleroderma, or immunocompromisedparticipants due to immunosuppressive or steroid therapy.

• Inadequate chest wall tissue due to damage caused by radiotherapy, tight skin graftsor radical resection of the pectoralis major muscle.

• Participant who is included in another pharmacological or device research study.

• Participants with a previous history of failure of attempted tissue expansion orbreast implant placement at the site of intended expansion.

• Participant with a history of silicone sensitivity.

• Employees of Establishment Labs or any of its divisions or sites; Researchers oranyone who collaborates on the study or is directly related to a person working forEstablishment Labs, sites or commissioned Researchers.